Del Mar Reynolds Medical, Ltd.

Complete recall history across all FDA and CPSC categories — 8 total recalls

Del Mar Reynolds Medical, Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (8)

FDA medical device enforcement actions by Del Mar Reynolds Medical, Ltd.

Date Product Reason Class
Apr 14, 2017 Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in ... Reports of the Canister Carrier breaking during absorbent exchange or during ... Class II
Feb 8, 2017 Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous... Spacelabs has received reports of the Arkon Anesthesia Delivery System, Model... Class II
Mar 5, 2015 Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacela... Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (... Class II
Mar 10, 2014 SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installe... The System may go into a controlled failed state if a series of parameters on... Class I
Oct 17, 2013 CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation,... Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part ... Class I
Jun 7, 2013 Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workst... Spacelabs ARKON Anesthesia System is recalled due to software defect. The Sy... Class II
Jan 15, 2013 Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Worksta... A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and S... Class I
Nov 2, 2012 BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthe... The BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators were sh... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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